FDA grants Fast Track Designation for Verastem’s combination NSCLC treatment

Verastem Oncology has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s investigational RAF/MEK clamp, avutometinib, in combination with Amgen’s KRAS G12C inhibitor, Lumakras (sotorasib) for the treatment of patients with KRAS G12C-mutant metastatic non-small cell lung cancer (NSCLC).
Preliminary results from the phase 1/2 RAMP 203 study evaluating the safety and efficacy of this combination in patients with KRAS G12C-mutant NSCLC demonstrated confirmed responses in both KRAS G12C inhibitor resistant and naïve patients.
Dan Paterson, president and chief executive officer of Verastem Oncology, commented: “Receiving Fast Track Designation for the combination of avutometinib and sotorasib reinforces the importance of improving the depth of MAPK pathway inhibition to enhance tumour regression relative to KRAS G12C inhibition alone and the potential of the combination of avutometinib and sotorasib in KRAS G12C mutant locally advanced or metastatic NSCLC. Given that KRAS G12C is the most common KRAS mutation in NSCLC, the advancement of the combination is important in understanding potential new treatment approaches. We look forward to continued interaction with the FDA as we advance the development of this promising treatment regimen.”
According to the company’s press release, ‘These initial RAMP 203 results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October, 2023. Enrollment of patients with KRAS G12C-mutant NSCLC who are either naïve to or previously treated with a KRAS G12C inhibitor is ongoing in the expansion phase of RAMP 203 with updated results expected in the first half of 2024.’